BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 12225486 · Received July 26, 2021

    Report

    Report Number
    3006630150-2021-04052
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 9, 2019
    Report Date
    July 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE OF YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2208700, MODEL: SC-2208-70, SERIAL: (B)(4), BATCH: 146849/158654.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE SPINAL CORD STIMULATOR (SCS) DEVICE BEING NONFUNCTIONAL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121848 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 173408

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention